Speeding Approval in the Era of Electronic Submissions

Even though it has been two years since the electronic system was implemented, many pharmaceutical companies are still struggling to navigate the approval process efficiently.

An Investigational New Drug (IND) Application submitted to the US Food & Drug Administration (FDA) can easily run 10 or more volumes, largely consisting of reviews and copies of published studies of the drug in question. Many of the documents required come from published literature sources, mainly in the form of scientific articles. Obtaining, assembling, transmitting and managing this volume of materials is a major task for any pharmaceutical company, whether it submits traditional paper documents to the regulatory agency or opts for electronic submission—and let’s face it, it can be time-consuming, expensive and downright exhausting. In 2008, the FDA mandated that all electronic submissions adhere to the electronic Common Technical Document (eCTD) format. This eCTD standard poses additional distinct challenges as the scientific literature is not published in this format, but needs to be reformatted to fit the FDA standard. Even though it has been two years since the electronic system was implemented, many pharmaceutical companies are still struggling to navigate the approval process efficiently. There is help. Acquiring the necessary published literature for the regulatory approval process can be effectively standardized and facilitated by a dedicated professional document preparation service. Based on my experience in this area, I would like to share how such a service can speed the drug approval process and help companies save valuable resources. (Read More)

Source: PharmaManufacturing.com